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Earlier today Sequenom, Inc. filed a Petition for Writ of Certiorari in the Supreme Court of the United States, challenging the decision of the United States Court of Appeals for the Federal Circuit in Ariosa Diagnostics, Inc. v. Sequenom, Inc. If the Supreme Court takes this case, which they absolutely should, they will be required to reconsider the overwhelming breadth and scope of their prior ruling in Mayo Collaborative Servs. v. Prometheus Labs.

The single question presented by Sequenom in the petition for certiorari is as follows:

Whether a novel method is patent-eligible where: (1) a researcher is the first to discover a natural phenomenon; (2) that unique knowledge motivates him to apply a new combination of known techniques to that discovery; and (3) he thereby achieves a previously impossible result without preempting other uses of the discovery?

“We think that there is a compelling case for the Supreme Court to step in,” said Sequenom’s counsel Thomas Goldstein, the founder of the widely popular SCOTUS Blog. “The issue turns entirely on how to read the Court’s cases. The stakes could not be higher for the life sciences. And this is undoubtedly a breakthrough invention that illustrates the harm from the Federal Circuit’s ruling.”

Reasons for Granting Cert.

Before launching into a detailed analysis of why the Supreme Court should grant certiorari in this particular case, Sequenom makes the following general argument in the brief, which basically makes the point that the sweeping language of Mayo simply cannot mean what it says because when applied as written even groundbreaking, novel, non-obvious and highly useful innovations are no longer patent eligible. The brief explains (at pages 11-12):

This is as straightforward a certiorari candidate as any patent case can be. It is manifestly important: A host of judges and amici have stressed that the result below is untenable— invalidating previously irreproachable inventions and precipitating what Judge Lourie called “a crisis of patent law and medial innovation.” Pet.App. 78a. Those judges have likewise emphasized that the only clarifications that can avoid such results “must come from the Supreme Court.” Pet.App. 84a (Dyk, J.); Pet.App. 20a-21a (Linn, J.). And this is the vehicle this Court needs to provide that clarification: Every opinion below agrees that this case tests Mayo’s uncertain limits by invalidating an otherwise plainly meritorious invention. As Mayo’s author has acknowledged, that case could only “sketch an outer shell” of its test, Arg. Tr. 28, Alice v. CLS Bank Int’l, 134 S. Ct. 2347 (2014) (No. 13-298) (Breyer, J.), partly because it was hard to “figure out much … to go beyond … an obvious case.” Id. 10-11. Here, unlike Mayo, every intuition points towards patent-eligibility. And yet the Federal Circuit felt compelled by Mayo to condemn this meritorious patent—and, a fortiori, the patents underlying an entire, vital field of American healthcare innovation. If, as several judges below observed, that cannot be what Mayo intended, this is precisely the case in which this Court needs to say so.

The case itself shows why. Sequenom invested enormously in developing and validating a recognized “breakthrough” for clinical use, only to see that investment radically undermined by fast-following competitors trading on an uncertain legal doctrine. As several judges below explained, even they find it hard to reconcile Mayo’s test with other language in the opinion, Pet.App. 23a-24a (Linn, J.), let alone other language in other opinions, Pet.App. 90a-91a (Dyk, J.). It is infinitely harder for businesses to decipher where the doctrine now stands, especially because it (now) seems divorced from intuitions about patent-eligibility for “revolutionary” inventions like this one. Right now, Section 101 doctrine lacks any discernable limits, and so no company can trust in the patent system when deciding whether to invest in bringing an invention to market. This issue has become particularly life-threatening to life-science innovators. Pet.App. 77a-78a (Lourie, J.); Pet.App. 90a (Dyk, J.). And so unless this Court clarifies some limits on Section 101, a doctrine that was meant to be a narrow exception will become the rule by default in at least this industry, and likely beyond.

The Invention

This wayward patent tale begins back in 1996, when two doctors discovered cell-free fetal DNA (cffDNA) circulating in maternal plasma. They used that discovery to invent a test for detecting fetal genetic conditions in early pregnancy that avoided dangerous, invasive techniques that are potentially harmful to both the mother and the fetus. They filed a patent application, which matured into U.S. Patent No. 6,258,540, which claims certain methods of using cffDNA. The patent teaches technicians to take a maternal blood sample, keep the non-cellular portion (which was “previously discarded as medical waste”), amplify the genetic material that only they had discovered was present, and identify paternally inherited sequences as a means of distinguishing fetal and maternal DNA. The claimed method does not preempt other demonstrated uses of cffDNA.

At Trial

In response to letters threatening claims of infringement from Sequenom, Ariosa Diagnostics, Inc., Natera, Inc. and Diagnostics Center, Inc. each filed separate declaratory judgment actions from December 2011 through early 2012 against Sequenom alleging that they did not infringe the ‘540 patent.

The district court determined that the claims of the ’540 patent in question were directed to the natural phenomenon of paternally inherited cffDNA and that the claims did not add enough to the natural phenomenon to make the claims patent eligible under § 101. The district court determined that the steps of amplifying and detecting were well-understood, routine, or conventional activity in 1997 (the critical date), when the application for the ’540 patent was filed. The district court concluded that the ’540 patent was not directed to patentable subject matter because the only inventive component of the processes of the ’540 patent is to apply those well-understood, routine processes to paternally inherited cffDNA, a natural phenomenon.

On Appeal to the Federal Circuit

Ultimately, the Federal Circuit concluded that the discovery in question was “a significant contribution to the medical field,” but that did not matter insofar are patent eligibility is concerned.

The Federal Circuit, in the original panel opinion authored by Judge Reyna, explained that it was undisputed that the existence of cffDNA in maternal blood is a natural phenomenon. It was further clear that the inventors did not create or alter any of the genetic information encoded in the cffDNA. The method covered in the patent claims ends with paternally inherited cffDNA, which is also a natural phenomenon. The method, therefore, begins and ends with a natural phenomenon. Thus, the claims were found to be directed to matter that is naturally occurring.

The inquiry did not end here, however, because the claims at issue are drawn to naturally occurring phenomena, it was necessary under the Supreme Court’s so-called Mayo framework to ask a second question – whether the elements of the claim contain sufficient inventive conception to transform the claimed naturally occurring phenomenon into a patent eligible invention. The Federal Circuit concluded that the claims did not satisfy this second prong of Mayo.

Judge Reyna wrote:

The method at issue here amounts to a general instruction to doctors to apply routine, conventional techniques when seeking to detect cffDNA. Because the method steps were well-understood, conventional and routine, the method of detecting paternally inherited cffDNA is not new and useful.

Judge Linn wrote a separate concurring opinion concluding that given the unnecessarily sweeping language of the Supreme Court’s decision in Mayo he was constrained to agree that the patent claims at issue were ineligible. Judge Linn explained that the Supreme Court lumped all post-solution conventional activity together as if it necessarily had to be qualitatively the same.

Judge Linn wrote:

The Supreme Court’s blanket dismissal of conventional post-solution steps leaves no room to distinguish Mayo from this case, even though here no one was amplifying and detecting paternally-inherited cffDNA using the plasma or serum of pregnant mothers. Indeed, the maternal plasma used to be “routinely discarded,” because, as Dr. Evans testified, “nobody thought that fetal cell-free DNA would be present.”

Judge Linn concluded “Sequenom’s invention is truly meritorious.”

Conclusion

It is unfortunate that the Federal Circuit did not recognize that a discovery as significant as the one embodied in the ‘540 patent is patent eligible. Of course, it is hard to argue with Judge Linn’s analysis. It should not be that way, but because of the extraordinary breadth of the decision in Mayo it has to be that way.

It seems clear that the Supreme Court did not intend to destroy medical research or make it impossible to patent groundbreaking medical advances, but that is what Mayo has done when the language of the Supreme Court is faithfully applied, at least to the extent it can be applied. The Supreme Court has arbitrarily chosen which of its own prior decisions to follow and which decisions ignore, while simultaneously refusing to read and enforce the laws passed by Congress even when the statue is but a single sentence (as is 35 U.S.C. 101, which clearly says discoveries are patent eligible).

It is time for the Supreme Court to stand up and face the music. If they did not intent to render groundbreaking medical innovations patent ineligible they must take this case and they must place real, consequential limits on Mayo.

The Author

Gene Quinn
is a Patent Attorney and Editor and President & CEO ofIPWatchdog, Inc.. Gene founded IPWatchdog.com in 1999. Gene is also a principal lecturer in the PLI Patent Bar Review Course and Of Counsel to the law firm of Berenato & White, LLC. Gene’s specialty is in the area of strategic patent consulting, patent application drafting and patent prosecution. He consults with attorneys facing peculiar procedural issues at the Patent Office, advises investors and executives on patent law changes and pending litigation matters, and works with start-up businesses throughout the United States and around the world, primarily dealing with software and computer related innovations. Gene is admitted to practice law in New Hampshire, is a Registered Patent Attorney and is also admitted to practice before the United States Court of Appeals for the Federal Circuit. CLICK HERE to send Gene a message.

Warning & Disclaimer: The pages, articles and comments on IPWatchdog.com do not constitute legal advice, nor do they create any attorney-client relationship. The articles published express the personal opinion and views of the author and should not be attributed to the author’s employer, clients or the sponsors of IPWatchdog.com. Read more.

Discuss this

There are currently 16 Comments comments.

EGMarch 21, 2016 3:18 pm

“It is time for the Supreme Court to stand up and face the music. If they did not intent to render groundbreaking medical innovations patent ineligible they must take this case and they must place real, consequential limits on Mayo.”

Hey Gene,

Couldn’t agree more. As opposed to just “bullying” the Federal Circuit, and trouncing it everytime it’s unable to divine what SCOTUS won’t explain (or define), it’s time for SCOTUS to “own up” to the mess it’s created on subject matter eligibility with Mayo, and finally clarify what medical diagnostic methods ARE patent-eligible under Mayo.

KenMarch 21, 2016 4:39 pm

“It should not be that way, but because of the extraordinary breadth of the decision in Mayo it has to be that way.”

I don’t know if I agree with this – if the Federal Circuit wanted to, I think they could have found a way to read Mayo that didn’t go this far. Then, the Supreme Court could simply deny cert on that – to in effect endorse a limiting of Mayo. But instead, the Federal Circuit “conveniently” takes the most expansive view of Mayo and keeps the burden on patentees to seek an affirmative change from the Supreme Court.

CuriousMarch 21, 2016 6:54 pm

But instead, the Federal Circuit “conveniently” takes the most expansive view of Mayo and keeps the burden on patentees to seek an affirmative change from the Supreme Court
The same thing could be said about Alice. The Supreme Court, in Alice, did not deviate significantly from Bilski. Instead, they essentially said that Alice is nearly identical to Bilski (with the exception of the computer elements recited in Alice) and held that Alice is directed to an abstract idea. However, the District Courts (blessed by the many rulings of the Federal Circuit) have expanded Alice far beyond the words of the decision.

It is funny (and very, very sad) that the judicially-made exceptions to statutory law (i.e., 35 USC 101) are being interpreted expansively. Shouldn’t these judicially-made exceptions be interpreted narrowly? Instead, these exceptions are being interpreted so broadly by courts that nearly any invention has a cloud of uncertainty over it. The Progress of Science and useful Arts is not promoted when the law (as interpreted by the Courts) casts considerable uncertainty over whether any issued patent is valid.

While SCOTUS needs to take some blame for their inconsistent and misguided decisions, I think the majority of the blame needs to be laid at the feet of the Federal Circuit, who seem to think that there is no limit to the scope of the exceptions to 35 USC 101 — so much so that the exceptions threaten to swallow the rule (or in this case, the law).

EGMarch 22, 2016 7:42 am

Admittedly, the Federal Circuit (as Newman in dissent suggested) could have made some effort to cabin the effects of both Mayo and Myriad in this case. But let’s not forget that SCOTUS jumped all over the Federal Circuit in both Mayo and Myriad, as well as other case involving patent law. Thus, it’s not surprising that the Federal Circuit has grown weary, as well as wary of trying to divine what the Royal Nine view as the standard for patent-eligibility as it relates to medical diagnostics. I still put primary blame for this mess on SCOTUS, so as the Sequenom says, its up to them to “clean it up.”

A Rational PersonMarch 22, 2016 12:06 pm

Gene,

“It seems clear that the Supreme Court did not intend to destroy medical research or make it impossible to patent groundbreaking medical advances”

That’s less clear to me. The Court explicitly decided to ignore the amici that argued “that a principle of law denying patent coverage here will interfere significantly with the ability of medical researchers to make valuable discoveries, particularly in the area of diagnostic research” and favored the arguments of other “medical experts”.

Gene QuinnMarch 22, 2016 12:49 pm

A Rational Person-

I’m willing to give the Supreme Court the benefit of the doubt, although I know they don’t deserve it on patent matters.

The way I arrive at giving them the benefit of the doubt here is because of how derisive the Supreme Court was of the patent claims and the underlying invention in Mayo. In fact, I think you could say that the Supreme Court has been derisive in all the patent eligibility cases they have decided recently. Faced with a real innovation that covers a real scientific breakthrough I have to think they would come out differently.

I also think they know patent law so little that they actually think that their test, which I’m sure they think is brilliant, was perfectly fine to separate non-inventions from patent worth inventions. Obviously, the test did no such thing.

-Gene

Joachim MartilloMarch 22, 2016 12:57 pm

SCOTUS has taken the position that because detection of a natural phenomenon by standard well-known procedures simply does not merit the status of synthetic or posterior knowledge, the patent was not directed to patent-eligible subject matter. Kant would probably have agreed.

Would SCOTUS have invalidated the Ether patent (US4848) if its claim were drafted to modern standards?

Probably not.

Paul ColeMarch 22, 2016 2:10 pm

If readers took the trouble to parse Mayo, Myriad and possibly Alice with the rigour taught in US law schools, rather than simply lifting attractive-seeming slabs of dicta from the opinions, the Supreme Court would be seen to be far more rational and cautious than is currently believed. The difficulty arises because of over-broad and inappropriate interpretation by the lower courts.

And although Judge Linn may well have had very good reasons for his cautious non-dissent, any lawyer with reasonable competence in patent law and with reasonable knowledge of the life sciences could not merely have distinguished Ariosa but have driven a 32-ton articulated truck between the facts in Ariosa and those in Mayo.

The panel majority, unfortunately, were arts-trained economists with at best a 5-year part-time involvement in patent law and little or no knowledge of the life sciences. In other words, despite their high judicial positions, they were neophytes. It is an interesting student exercise to make a list of the crass legal and factual errors in the majority opinion.

With great sadness it will take the Supreme Court to sort out the mess. We should all hope that the petition succeeds and that a sensible and workable test emerges.

A Rational PersonMarch 22, 2016 2:27 pm

Paul@8

“And although Judge Linn may well have had very good reasons for his cautious non-dissent, any lawyer with reasonable competence in patent law and with reasonable knowledge of the life sciences could not merely have distinguished Ariosa but have driven a 32-ton articulated truck between the facts in Ariosa and those in Mayo.”

And what will you say if the Supreme Court does not grant cert in Ariosa or finds the claims in Ariosa every bit as patent ineligible as in Mayo?

Edward HellerMarch 22, 2016 2:58 pm

Testing maternal plasma for paternal DNA was new.

In Mayo, every physical act was old and conventional. The physical test here is new for the reasons stated by Linn and the Petition.

The Federal Circuit majority has grossly misunderstood Mayo.

valuationguyMarch 22, 2016 3:40 pm

The Federal Circuit isn’t misunderstanding it at all in my opinion. They are using the breadth of the language to pursue their agenda….which is to reduce/limit/expunge patent damages to the best of their ability. It’s been obvious since before Rader was forced off the court that many on the CAFC were ACTIVELY destroying patent owners ability to recover damages from infringers.

The amount of poorly thought out decisions from the CAFC over the past 6 six years shows how fast activist justices can ruin an entire area of law in a short period.

I agree that the Supreme Court’s language actually opened the door….but a reasonable court wouldn’t have trying to fit an elephant through the front door…destroying the door itself.

Edward HellerMarch 22, 2016 4:04 pm

ValGuy, can you explain why the Federal Circuit would want to drive down the value of patents as an agenda by

1. limiting damages,
2. finding everything invalid and not infringed, and
3. giving the PTO carte blanche in the new post grant proceeding to do as much damages as they please?

A Rational PersonMarch 22, 2016 5:06 pm

Edward@10

“Testing maternal plasma for paternal DNA was new.

In Mayo, every physical act was old and conventional. The physical test here is new for the reasons stated by Linn and the Petition.

The Federal Circuit majority has grossly misunderstood Mayo.”

Same challenge as to Paul@8:

And what will you say if the Supreme Court does not grant cert in Ariosa or finds the claims in Ariosa every bit as patent ineligible as in Mayo?

You have a lot more faith in the Supreme Court’s understanding of science and technology than I do.

AnonMarch 22, 2016 6:08 pm

Mr. Cole,

Please stop with that “if only the people” line.

These “only the people” are the lower courts.

Your call for restraint, while admirable, simply cannot be found in the writings of the Supreme Court like you want to find them.

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